BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE OEC MEDICAL SYSTEMS, INC

    Reg #: 1720753 · FEI: 1720753 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    GE OEC MEDICAL SYSTEMS, INC
    Registration Number
    1720753
    FEI Number
    1720753
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    384 N WRIGHT BROTHERS DR
    City
    SALT LAKE CITY
    State
    UT
    ZIP
    84116
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974355

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Monitor, Patient Position, Light-Beam IWE

    Proprietary Names

    OEC 9800 OEC 3D OEC Elite OEC 9800 Plus OEC FluoroTrak 9800 Plus OEC 9900 Elite OEC Elite MiniView Laser Aimer Light beam patient position indicator (laser) OEC Olympus 9900 Elite Plus

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only